748 - Hello what kind of references are required to make a claim about number of patients treated with drug/device X worldwide? and about availability in x number of countries? Does Data on file suffice? if not what other references would be expected to approve this claim?

748 - Hello what kind of references are required to make a claim about number of patients treated with drug/device X worldwide? and about availability in x number of countries? Does Data on file suffice? if not what other references would be expected to approve this claim?

This topic has been deleted. Only users with topic management privileges can see it.

Data on file would be acceptable for a claim about “# of patients treated with drug/device X worldwide”. Likewise, availability in X countries could be supported by data on file. Note that these claims should not be linked to or suggest safety or efficacy.